CN108904442A - A kind of florfenicol solution agent and preparation method thereof - Google Patents
A kind of florfenicol solution agent and preparation method thereof Download PDFInfo
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- CN108904442A CN108904442A CN201810900658.6A CN201810900658A CN108904442A CN 108904442 A CN108904442 A CN 108904442A CN 201810900658 A CN201810900658 A CN 201810900658A CN 108904442 A CN108904442 A CN 108904442A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Animal Behavior & Ethology (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention provides a kind of florfenicol solution agent, is made of Florfenicol, organic solvent, cosolvent, wetting agent, pH buffer, solution stabilizer and water.On the one hand florfenicol solution agent of the invention solves the problems, such as the unstable easy precipitation of florfenicol soluble powder clinical application in the prior art；On the other hand it solves in existing florfenicol solution agent, needs using dimethylformamide, dimethyl acetamide, dimethyl sulfoxide with penetrating odor and toxic side effect etc. as solvent bring adverse reaction.
Description
Technical field
The present invention relates to a kind of Florfenicol dosage form preparation field, in particular to a kind of preparation of florfenicol solution agent.
Background technique
Florfenicol (florfenicol) is also known as Florfenicol, is that Schering Plough company of the U.S. was developed into 1988
A kind of dedicated chloromycetin broad spectrum antibiotic of novel veterinarian of function belongs to U.S. FDA and authenticates one of the 4 kinds of antibacterial agents passed through.Its
Chemical name is D (+)-Soviet Union -1- to methylsulfonyl phenyl -2- dichloro acetamino -3- fluorine propyl alcohol.It has has a broad antifungal spectrum, absorbs
Well, it is distributed the features such as wide, safe and efficient, drug resistance incidence is low in vivo, fowl bacterial disease caused by sensitive bacteria is controlled
Therapeutic effect is significant.
Compared with similar antibiotic, although Florfenicol function admirable, due to its water-soluble its biology benefit of too poor influence
Expenditure annoyings always clinical application.To solve its water solubility problems, domestic and foreign scholars expand numerous studies, are prepared
It is to study more technique direction relatively at present for soluble powder, although achieving some achievements, soluble powder is in medication
Stability be but difficult to ensure；Then, the patented technologies such as CN105796488A trial is made into solution, but dimethyl formyl
The introducing of amine, dimethyl acetamide, dimethyl sulfoxide equal solvent causes its animal palatability very poor, not can effectively solve clinic still
The problem of medication difficulty, simultaneously because above-mentioned organic solvent has penetrating odor and toxicity, during a line pharmaceutical production personnel have
Malicious risk.Therefore, the water solubility for how promoting Florfenicol guarantees its stability in the solution, reduces existing solution and produces
The toxic side effect of product improves the animal palatability of existing solution product, is clinical application urgent problem to be solved.
Summary of the invention
To solve the problems, such as that existing Florfenicol clinical application is difficult, it is high, solution-stabilized that the present invention provides a kind of solubility
And be free of the florfenicol solution agent of toxic side effect solvent.
To realize the above-mentioned technical purpose, the technical solution adopted by the present invention is：
A kind of florfenicol solution agent, it is steady by Florfenicol, organic solvent, cosolvent, wetting agent, pH buffer, solution
Determine agent and water composition；The organic solvent is the mixture of propylene glycol and glycerine, and the cosolvent is sodium citrate, institute
The wetting agent stated is tween or/and Span, and the pH buffer is citric acid, and the solution stabilizer is derivative for cellulose
Object.
Further, include in the florfenicol solution agent：Florfenicol 5~30% (W/V), propylene glycol 30-
50% (V/V), glycerine 8-20% (V/V), sodium citrate 1.8-2.2% (W/V), tween or/and Span 0.01-0.05%
(W/V), cellulose derivative 0.5-1.5% (W/V), appropriate citric acid, surplus are water.
Further, the content of the propylene glycol is 40-45% (V/V), and the content of glycerine is 8-12% (V/V).
Further, the pH value of the florfenicol solution agent is 5.5-7.5.
Further, the cellulose derivative be methylcellulose, sodium carboxymethylcellulose, ethyl cellulose,
One or more of hypromellose.
Preferably, the cellulose derivative is the mixture of ethyl cellulose and hypromellose.
Preferably, the cellulose derivative is hypromellose.
Preferably, the tween or/and Span are polysorbas20 or/and Span 20.
A kind of preparation method of florfenicol solution agent, including following preparation step：
1) after taking recipe quantity water that the cosolvent stirring and dissolving of recipe quantity is added, the wetting agent and organic solvent of recipe quantity is added
It is uniformly mixed, is warming up to 40-60 DEG C jointly, Florfenicol is added under stirring；
2) solution stabilizer of recipe quantity is added after being cooled to room temperature above-mentioned solution, is uniformly mixed；
3) be 5.5-7.5 with the pH value of pH buffer adjustment solution, after water constant volume, stir evenly to obtain the final product.
In the present invention, cosolvent be used to Florfenicol dissolution provide alkaline environment, promoted its solution rate and
Solubility, but Florfenicol is perishable in alkaline solution, and especially when pH value is greater than 12, solubility and solution rate are big
Width is promoted, but is inactivated after several minutes, to guarantee that stability of the Florfenicol in solution, the present invention are adjusted with pH buffer
The pH value of solution is 5.5-7.5, and forms pH buffering pair with cosolvent.Organic solvent removes the spy for having solvent in the present invention
Outside property, when also for solution stabilizer, to provide dissolution conditions, especially stabilizer be hypromellose, the water-alcohol ring of formation
Border can significantly reduce the viscosity of solution.Organic solvent is during storage and use, due to volatilizing and being diluted, effectively
Amount and concentration, which can reduce, causes Florfenicol to be precipitated, and stabilizer can effectively solve because organic solvent loss or concentration reduction are brought
Florfenicol be precipitated problem.Wetting agent can infiltrate Florfenicol, accelerate its dissolution in water-alcohol environment, otherwise fluorobenzene Buddhist nun
Solvent surface can be swum in for a long time by examining.It should be noted that Florfenicol, organic solvent, cosolvent and stabilization in the present invention
There should be positive correlation between the usage amount of agent；And accounting of the organic solvent in solution cannot be below 50% (V/V),
In propylene glycol and glycerine the negatively correlated property of dosage, but the dosage of glycerine cannot be below 8%.
By adopting the above technical scheme, the beneficial effect of the invention having is made to be：One aspect of the present invention efficiently solves existing
In technology the problem of florfenicol soluble powder clinical application unstable easy precipitation；On the other hand it is molten to solve existing Florfenicol
In liquor, need using dimethyl sulfoxide with penetrating odor and toxic side effect etc. as solvent bring adverse reaction.
Specific embodiment：
In order to make the objectives, technical solutions, and advantages of the present invention clearer, below in conjunction with specific embodiment, to this
Invention is further elaborated.It should be appreciated that specific embodiment described herein is used only for explaining the present invention, not
For limiting the present invention.
Embodiment 1
A kind of florfenicol solution agent, by Florfenicol 5g, propylene glycol 30ml, glycerine 20ml, sodium citrate 1.8g, department
Class 20 0.01g, ethyl cellulose 0.2g, hypromellose 0.3g, appropriate citric acid, water are quantitative to 100ml.
The preparation method of the florfenicol solution of the present embodiment, includes the following steps：
1) after sodium citrate stirring and dissolving is added in water intaking 20ml, wetting agent is added and organic solvent is uniformly mixed, it is common to rise
Florfenicol is added under stirring to 50 DEG C in temperature；
2) solution stabilizer is added after being cooled to room temperature above-mentioned solution, is uniformly mixed；
It 3) is 5.5 with the pH value of citric acid adjustment solution, 100ml after water constant volume is stirred evenly to obtain the final product.
Embodiment 2
A kind of florfenicol solution agent, by Florfenicol 20g, propylene glycol 42ml, glycerine 10ml, sodium citrate 2.0g,
Polysorbas20 0.02g, 20 0.02g of Span, hypromellose 1.2g, appropriate citric acid, water is quantitatively to 100ml.
The preparation method of the florfenicol solution of the present embodiment, includes the following steps：
1) after sodium citrate stirring and dissolving is added in water intaking 10ml, wetting agent is added and organic solvent is uniformly mixed, it is common to rise
Florfenicol is added under stirring to 40 DEG C in temperature；
2) solution stabilizer is added after being cooled to room temperature above-mentioned solution, is uniformly mixed；
It 3) is 7.5 with the pH value of citric acid adjustment solution, 100ml after water constant volume is stirred evenly to obtain the final product.
Embodiment 3
A kind of florfenicol solution agent, Florfenicol 30g, propylene glycol 50%ml, glycerine 8ml, sodium citrate 2.2g, department
20 0.05%g of class, hypromellose 1.5g, appropriate citric acid, water are quantitative to 100ml.
The preparation method of the florfenicol solution of the present embodiment, includes the following steps：
1) after sodium citrate stirring and dissolving is added in water intaking 10ml, wetting agent is added and organic solvent is uniformly mixed, it is common to rise
Florfenicol is added under stirring to 60 DEG C in temperature；
2) solution stabilizer is added after being cooled to room temperature above-mentioned solution, is uniformly mixed；
It 3) is 6.5 with the pH value of citric acid adjustment solution, 100ml after water constant volume is stirred evenly to obtain the final product.
The experiment of 4 solubization of embodiment
Florfenicol solution agent, commercially available florfenicol solution (10%) 5ml prepared by Example 1~3 respectively, implement
Stabilizer is the florfenicol solution agent of PEG preparation in example 3, and stabilizer is that the Florfenicol of cyclodextrin preparation is molten in embodiment 3
Liquor does not adjust the florfenicol solution agent of pH preparation in embodiment 3, does not add the fluorobenzene Buddhist nun of glycerine preparation in embodiment 3
Solution is examined, does not add the florfenicol solution agent of propylene glycol preparation in embodiment 3.
5 times, 10 times, 50 times, 100 times are diluted with water, it is then at room temperature that the placement 12 of above-mentioned solution agent solution is small
When, whether there is or not macroscopic sediments for observation solution, as a result such as the following table 1.
1 different solutions agent solution of table places 12h precipitating situation under different extension rates
5 melt water stability experiment of embodiment
Florfenicol solution agent, commercially available florfenicol solution (10%) 5ml prepared by Example 1~3 respectively, implement
Stabilizer is the florfenicol solution agent of PEG preparation in example 3, and stabilizer is that the Florfenicol of cyclodextrin preparation is molten in embodiment 3
Liquor does not adjust the florfenicol solution agent of pH preparation in embodiment 3, does not add the fluorobenzene Buddhist nun of glycerine preparation in embodiment 3
Solution is examined, does not add the florfenicol solution agent of propylene glycol preparation in embodiment 3.
100 times are diluted with water, above-mentioned solution agent solution is then placed into 6h, 12h, 18h and for 24 hours at room temperature, is seen
Examining solution, whether there is or not macroscopic sediment and colors, as a result such as the following table 2.
Precipitating situation in for 24 hours is put after the dilution of 2 different solutions agent solution 100 of table
Claims (9)
1. a kind of florfenicol solution agent, by Florfenicol, organic solvent, cosolvent, wetting agent, pH buffer, solution-stabilized
Agent and water composition, it is characterised in that：The organic solvent is the mixture of propylene glycol and glycerine, and the cosolvent is lemon
Lemon acid sodium, the wetting agent are tween or/and Span, and the pH buffer is citric acid, and the solution stabilizer is
Cellulose derivative.
2. a kind of florfenicol solution agent according to claim 1, it is characterised in that wrapped in the florfenicol solution agent
Contain：Florfenicol 5~30% (W/V), propylene glycol 30-50% (V/V), glycerine 8-20% (V/V), sodium citrate 1.8-
2.2% (W/V), tween or/and Span 0.01-0.05% (W/V), cellulose derivative 0.5-1.5% (W/V), citric acid are suitable
Amount, surplus is water.
3. a kind of florfenicol solution agent according to claim 1 or 2, it is characterised in that：The content of the propylene glycol is
40-45% (V/V), the content of glycerine are 8-12% (V/V).
4. a kind of florfenicol solution agent according to claim 1 or 2, it is characterised in that：The florfenicol solution agent
PH value be 5.5-7.5.
5. a kind of florfenicol solution agent according to claim 1 or 2, it is characterised in that：The tween or/and Span
For polysorbas20 or/and Span 20.
6. a kind of florfenicol solution agent according to claim 1 or 2, it is characterised in that：The cellulose derivative
For one or more of methylcellulose, sodium carboxymethylcellulose, ethyl cellulose, hypromellose.
7. a kind of florfenicol solution agent according to claim 6, it is characterised in that：The cellulose derivative is second
The mixture of base cellulose and hypromellose.
8. a kind of florfenicol solution agent according to claim 6, it is characterised in that：The cellulose derivative is hydroxyl
Third methylcellulose.
9. a kind of preparation method of florfenicol solution agent, it is characterised in that including following preparation step：
1) after taking recipe quantity water that the cosolvent stirring and dissolving of recipe quantity is added, wetting agent and the organic solvent mixing of recipe quantity is added
Uniformly, it is warming up to 40-60 DEG C jointly, Florfenicol is added under stirring；
2) solution stabilizer of recipe quantity is added after being cooled to room temperature above-mentioned solution, is uniformly mixed；
3) be 5.5-7.5 with the pH value of pH buffer adjustment solution, after water constant volume, stir evenly to obtain the final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810900658.6A CN108904442B (en) | 2018-08-09 | 2018-08-09 | Florfenicol solution and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810900658.6A CN108904442B (en) | 2018-08-09 | 2018-08-09 | Florfenicol solution and preparation method thereof |
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| CN108904442A true CN108904442A (en) | 2018-11-30 |
| CN108904442B CN108904442B (en) | 2021-04-06 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110448527A (en) * | 2019-09-23 | 2019-11-15 | 杭州百诚医药科技股份有限公司 | A kind of colchicin oral administration solution and its composition |
| CN111249232A (en) * | 2020-03-18 | 2020-06-09 | 潍坊富邦药业有限公司 | 30% florfenicol suspension and preparation method thereof |
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Cited By (3)
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|---|---|---|---|---|
| CN110448527A (en) * | 2019-09-23 | 2019-11-15 | 杭州百诚医药科技股份有限公司 | A kind of colchicin oral administration solution and its composition |
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| CN111249232A (en) * | 2020-03-18 | 2020-06-09 | 潍坊富邦药业有限公司 | 30% florfenicol suspension and preparation method thereof |
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| CN108904442B (en) | 2021-04-06 |
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